First WHO prequalified hepatitis C rapid test opens the door to expanded treatment

An article by WHO

December 12, 2016

WHO has just prequalified its first hepatitis C virus (HCV) rapid diagnostic test, a tool that will aid diagnosis of HCV in low- and middle-income countries and improve access to treatment.

“The fact that we now have very effective new medicines for HCV needs to be bolstered by effective and affordable diagnostics,” said Dr Suzanne Hill, WHO Director for Essential Medicines and Health Products. “This new quality-assured test is good news for the many people awaiting diagnosis and treatment.”

The newly prequalified test, SD BIOLINE HCV, by Standard Diagnostics, Inc. (South Korea), is a point-of-care diagnostic, which makes it particularly appropriate for low-resourced countries, where testing laboratories and trained personnel may be scarce. Resembling a pharmacy pregnancy test, it does not require hospital facilities or electricity and can be performed by health workers with limited training. The test gives a result within 20 minutes.

WHO acceptance of the test comes at a time when direct acting antivirals (DAAs), new and highly effective medicines for HCV, are becoming increasingly affordable and available in low- and middle-income countries.